This paper has been prepared thanks to the task force and endorsed during the general assembly meeting. It is a high level document.
Improvements in patient care are more significant than new market potential for the manufacturer as a result of the rising number of connected medical devices and the ongoing digitalisation of healthcare. The safety, security, and privacy of medical gadgets are simultaneously put in new and diverse sorts of danger. These connected medical devices include implantable medical devices like pacemakers, software-based medical devices like smartphone apps, and sensor-based technology like wearables. Modern regulatory frameworks are required to guarantee the safe and secure use of medical equipment.
A high degree of cybersecurity and competitiveness at the European and global levels depends on coherent, consistent, and harmonised regulatory requirements. Nevertheless, more and more national cybersecurity guidelines and regulations are being released at the moment, which causes the European frameworks to become more fragmented.
This paper document is only meant to reflect the state of the art at the time of creation because cybersecurity is an area that is constantly evolving on both a regulatory and technological level.
The purpose of this work is to make conformance assessment(s) of cybersecurity as efficient as possible without sacrificing quality because there aren’t many cybersecurity experts currently, and it’s expected that the situation will stay the same in the near future.